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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K952891
Device Name CRONEX LOW ABSORPTION CASSETTE
Applicant
The DU Pont Co.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Applicant Contact JEAN E BARTLETT
Correspondent
The DU Pont Co.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact JEAN E BARTLETT
Regulation Number892.1850
Classification Product Code
IXA  
Date Received06/23/1995
Decision Date 07/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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